The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Participant Focus Group / Interview Guide	Form and Instruction	Unchanged	Available
Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Modified	Available
Study Visit Survey	Form and Instruction	Modified	Available
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Modified	Repair queued
Release of Information Form	Form and Instruction	Unchanged	Repair queued
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged	Repair queued
NAT Acceptability Survey	Form and Instruction	Unchanged	Available
Participants in POC NAT Acceptability Survey	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Modified	Available
Study Visit Survey	Form and Instruction	Modified	Available
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form and Instruction	Modified	Repair queued
Release of Information Form	Form and Instruction	Unchanged	Available
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Modified	Available
Study Visit Survey	Form and Instruction	Modified	Available
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form and Instruction	Modified	Repair queued
Release of Information Form	Form and Instruction	Unchanged	Available
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged	Repair queued
Form 0920-1357 GAIN Study Visit Survey - Revised 09SEP2022	Form and Instruction	Modified	Available
Study Visit Survey	Form and Instruction	Modified	Repair queued
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	Repair queued
Release of Information Form	Form and Instruction	Unchanged	Available
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged	Repair queued
Monthly Study Report Form	Form and Instruction	Unchanged	Available
Monthly Study Report Form	Form and Instruction	Unchanged	Repair queued
Nonsubstantiative change request justification_GAIN_0920-1357.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2022-09-13	Repair queued
Att 16_GAIN patient information sheet_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-13	Repair queued
Att 9_Consent form GAIN study_HIV+ Group_clean_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group_changes accepted_082922.docx	Supplementary Document	Uploaded 2022-09-09	Repair queued
SSB_GAIN_060921.docx	Supporting Statement B	Uploaded 2021-06-17	Repair queued
Att 10_Consent Form_RCT Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 9_Consent form GAIN study_Gay City HIV+ Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 8_Consent form GAIN study_Testing PEP PrEP Group.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 7_Privacy impact assessment (PIA).pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 6_GAIN IRB approval letter.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 4_GAIN data sources and variables.docx	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 3_GAIN study activities and visual overview.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 2_60-Day FRN Published 12-21-2020.pdf	Supplementary Document	Uploaded 2021-06-16	Repair queued
Att 1_Auth Legislation.docx	Supplementary Document	Uploaded 2021-06-16	Available
SSA_GAIN_changes accepted_082922.docx	Supporting Statement A	Uploaded 2022-09-13	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
247958	Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged	Participant Focus Group / Interview Guide
247958	Acceptability/Feasibility Assessment Among Clinical and Community Providers	Form and Instruction	Unchanged
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Modified	GAIN Study Visit Survey - Revised 09SEP2022
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Modified	Study Visit Survey
247957	Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	Form and Instruction	Modified
247955	Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged	Release of Information Form
247955	Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	Form and Instruction	Unchanged
247954	Participants in POC NAT Acceptability Survey	Form and Instruction	Unchanged	NAT Acceptability Survey
247954	Participants in POC NAT Acceptability Survey	Form and Instruction	Unchanged
247953	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form and Instruction	Modified	GAIN Study Visit Survey - Revised 09SEP2022
247953	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form and Instruction	Modified	Study Visit Survey
247953	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	Form and Instruction	Modified
247952	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Unchanged	Release of Information Form
247952	Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	Form and Instruction	Unchanged
247950	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form and Instruction	Modified	GAIN Study Visit Survey - Revised 09SEP2022
247950	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form and Instruction	Modified	Study Visit Survey
247950	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	Form and Instruction	Modified
247949	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged	Release of Information Form
247949	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form	Form and Instruction	Unchanged
247948	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	GAIN Study Visit Survey - Revised 09SEP2022
247948	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified	Study Visit Survey
247948	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	Form and Instruction	Modified
247947	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged	Release of Information Form
247947	Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	Form and Instruction	Unchanged
247946	Monthly Study Report Form	Form and Instruction	Unchanged	Monthly Study Report Form
247946	Monthly Study Report Form	Form and Instruction	Unchanged
247945	Baseline Data Collection	Instruction	Unchanged

ICR Details

OMB Control No: 0920-1357	ICR Reference No: 202209-0920-005
Status: Historical Active	Previous ICR Reference No: 202103-0920-010
Agency/Subagency: HHS/CDC	Agency Tracking No: 0920-1357-22IR
Title: The GAIN (Greater Access and Impact with NAT) Study: Improving HIV Diagnosis, Linkage to Care, and Prevention Services with HIV Point-of-Care Nucleic Acid Tests (NATs)
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 04/13/2023
Retrieve Notice of Action (NOA)	Date Received in OIRA: 09/13/2022
Terms of Clearance:

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2024	12/31/2024	12/31/2024
Responses	4,898	0	4,898
Time Burden (Hours)	1,067	0	1,067
Cost Burden (Dollars)	20,848	0	20,848

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Abstract: GAIN is an implementation study to compare a point-of-care nucleic acid HIV test (HIV RNA POC NAT) to standard lab-based HIV testing. These data will describe the real-world performance and clinical effects of HIV RNA POC NAT testing. CDC will not receive any personally-identifiable information. This Non-Substantive Change Request is submitted to modify the incentives provided to study groups and to improve study implementation logistics. The original plan offered varying incentives by study group which presents operational challenges. The change provides a consistent incentive plan across the primary study groups and also modifies language in consent forms. There is no change to the approved burden hours.

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Authorizing Statute(s): US Code: 42 USC 241 Name of Law: Public Health Service Act
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 83087	12/21/2020
30-day Notice:	Federal Register Citation:	Citation Date:
	86 FR 33294	06/24/2021
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 12

table that charts list of burden

IC Title	Form No.	Form Name
Acceptability/Feasibility Assessment Among Clinical and Community Providers	n/a	Participant Focus Group / Interview Guide
Baseline Data Collection
Monthly Study Report Form	n/a	Monthly Study Report Form
Participants in Cross-sectional Comparison of Several POC NATs - ROI Form	n/a	Release of Information Form
Participants in Cross-sectional Comparison of Several POC NATs - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in POC NAT Acceptability Survey	n/a	NAT Acceptability Survey
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - ROI Form	n/a	Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - ROI Form	n/a	Release of Information Form
Participants in Prospective Study of HIV-negative Patients Seeking HIV Testing and/or PrEP Services - Study Visit Survey	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - ROI Form	n/a	Release of Information Form
Participants in RCT of POC NAT or Standard of Care for HIV-positive Patients - Study Visit Form	0920-1357, n/a	Study Visit Survey ,   GAIN Study Visit Survey - Revised 09SEP2022

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ICR Summary of Burden

table that charts list of burden

	Total Approved	Previously Approved	Change Due to New Statute	Change Due to Agency Discretion	Change Due to Adjustment in Estimate	Change Due to Potential Violation of the PRA
Annual Number of Responses	4,898	4,898	0	0	0	0
Annual Time Burden (Hours)	1,067	1,067	0	0	0	0
Annual Cost Burden (Dollars)	20,848	20,848	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: No

Burden Increase Due to:

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $1,346,479

Does this IC contain surveys, censuses, or employ statistical methods? Yes Part B of Supporting Statement

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     No

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(i) Why the information is being collected;

(ii) Use of information;

(iii) Burden estimate;

(iv) Nature of response (voluntary, required for a benefit, or mandatory);

(v) Nature and extent of confidentiality; and

(vi) Need to display currently valid OMB control number;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

Certification Date: 09/13/2022

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